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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Over-the-Counter

NeilMed SinuFrin Decongestant Nasal Solution Recalled for Sub-potency

Agency Publication Date: June 28, 2024
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Summary

NeilMed Pharmaceuticals Inc is recalling 20,370 bottles of SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution because the medication was found to be sub-potent. This means the product is less effective than intended and may not provide the 12-hour relief from nasal congestion promised on the label. The recall affects 0.5 fl oz (15 ml) bottles sold nationwide under lot number SD134.

Risk

Because the drug is weaker than required, consumers may not experience the expected relief from nasal congestion, leading to persistent symptoms. No injuries or adverse reactions have been reported in connection with this recall.

What You Should Do

  1. This recall affects NeilMed SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution sold in 0.5 fl oz (15 ml) bottles.
  2. Identify the product by checking the packaging for NDC 13709-325-01, UPC 7 05928 09001 9, and lot number SD134 with an expiration date of 10/31/2026.
  3. If you have health concerns regarding the use of this product, contact your healthcare provider or pharmacist.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact NeilMed Pharmaceuticals Inc at 877-477-8633 for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution (0.5 fl oz)
Variants: 0.5 fl oz (15 ml) bottle
UPC Codes:
705928090019
Lot Numbers:
SD134 (Exp 10/31/2026)
NDC:
13709-325-01

Recall #: D-0569-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94853
Status: Active
Manufacturer: Neilmed Pharmaceuticals Inc
Sold By: Retail pharmacies; Drug stores
Manufactured In: United States
Units Affected: 20,370 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.